FREEDOM(R) STEMMED TIBIAL COMPONENTS


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K111785
Device Name FREEDOM(R) STEMMED TIBIAL COMPONENTS
Applicant
MAXX ORTHOPEDICS, INC.
2260 butler pike, suite 100
plymouth meeting, 
PA 
19462

Applicant Contact nache dave
Correspondent
MAXX ORTHOPEDICS, INC.
2260 butler pike, suite 100
plymouth meeting, 
PA 
19462

Correspodent Contact nache dave
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 06/24/2011
Decision Date 06/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Traditional
Reviewed by Third Party No

Combination Product

No